FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,503 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 1033-1044 of 1503 letters

ALApproval Letter
Approval Letter APOTEX (Apr 6, 2026)
FDA issued an approval letter for NINTEDANIB ESYLATE on 2026-04-06. The source metadata identifies ANDA 219227 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 6, 2026
US FDA• NINTEDANIB ESYLATE
WLWarning Letter
Warning Letter mohawksmoke.com (Apr 3, 2026)
FDA issued a warning letter to mohawksmoke.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic source-metadata screening identifies discussion of Labeling, claims, and misbranding, Tobacco product authorization and marketing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 3, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter The Fish Aid (Apr 3, 2026)
FDA issued a warning letter to The Fish Aid concerning Unapproved New Animal Drug Products. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedApr 3, 2026
US FDA• Unapproved New Animal Drug Products
WLWarning Letter
Warning Letter Ridley USA Inc. (Apr 3, 2026)
FDA issued a warning letter to Ridley USA Inc. concerning CGMP/Medicated Feeds/Adulterated. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Manufacturing and CGMP controls, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 3, 2026
US FDA• CGMP/Medicated Feeds/Adulterated
WLWarning Letter
Warning Letter DK Hardware Supply (Apr 3, 2026)
FDA issued a warning letter to DK Hardware Supply concerning Unapproved New Animal Drug Products. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 3, 2026
US FDA• Unapproved New Animal Drug Products
ALApproval Letter
Approval Letter BIONPHARMA (Apr 2, 2026)
FDA issued an approval letter for STAVZOR on 2026-04-02. The source metadata identifies NDA 022152 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 2, 2026
US FDA• STAVZOR
ALApproval Letter
Approval Letter MERZ (Apr 2, 2026)
FDA issued an approval letter for INBRIJA on 2026-04-02. The source metadata identifies NDA 209184 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 2, 2026
US FDA• INBRIJA
ALApproval Letter
Approval Letter ELI LILLY AND CO (Apr 2, 2026)
FDA issued an approval letter for FOUNDAYO on 2026-04-02. The source metadata identifies NDA 220934 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 2, 2026
US FDA• FOUNDAYO
ALApproval Letter
Approval Letter NOVARTIS (Apr 2, 2026)
FDA issued an approval letter for ARZERRA, KESIMPTA on 2026-04-02. The source metadata identifies BLA 125326 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 2, 2026
US FDA• ARZERRA / KESIMPTA
ALApproval Letter
Approval Letter AKEBIA (Apr 2, 2026)
FDA issued an approval letter for VAFSEO on 2026-04-02. The source metadata identifies NDA 215192 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 2, 2026
US FDA• VAFSEO
ALApproval Letter
Approval Letter ABBVIE (Apr 2, 2026)
FDA issued an approval letter for DEPAKOTE, DEPAKOTE ER on 2026-04-02. The source metadata identifies NDA 018723, NDA 019680, NDA 021168 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedApr 2, 2026
US FDA• DEPAKOTE / DEPAKOTE ER
WLWarning Letter
Warning Letter Purolea Cosmetics Lab (Apr 2, 2026)
FDA issued a warning letter to Purolea Cosmetics Lab concerning CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Laboratory controls and testing, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedApr 2, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Page 87 of 126

1…85 86 87 88 89…126

Approval Letter APOTEX (Apr 6, 2026)

Warning Letter mohawksmoke.com (Apr 3, 2026)

Warning Letter The Fish Aid (Apr 3, 2026)

Warning Letter Ridley USA Inc. (Apr 3, 2026)

Warning Letter DK Hardware Supply (Apr 3, 2026)

Approval Letter BIONPHARMA (Apr 2, 2026)

Approval Letter MERZ (Apr 2, 2026)

Approval Letter ELI LILLY AND CO (Apr 2, 2026)

Approval Letter NOVARTIS (Apr 2, 2026)

Approval Letter AKEBIA (Apr 2, 2026)

Approval Letter ABBVIE (Apr 2, 2026)

Warning Letter Purolea Cosmetics Lab (Apr 2, 2026)